Biospecimens Interest Group

Mission:Serve as an educational and tutorial vehicle for disseminating information, best practices, regulations, and ethical/legal information formulated and issued by various NIH offices, federal agencies and other leading biospecimens organizations.

Vision:

1.To create a place where all stakeholders may exchange scientific data, ideas, and information concerning the creation and use of high quality biospecimens for research, assay validation, technology development and other appropriate uses.

2.To promote and facilitate interaction between NIH intramural and extramural stakeholders who are interested in and involved with a variety of clinically-oriented, translational research projects using high quality biospecimens.

3.To encourage leading stakeholders to address critical elements in study design and statistical analysis of data to facilitate the production of accurate, optimal, and clinically meaningful results (best outcome).

4.To educate stakeholders about the potential barriers and obstacles that may obstruct the sharing and collaboration between stakeholders across different organizations and countries.

5.To increase the awareness for the necessity of high quality biospecimens and the harmonization, and when appropriate, standardized procedures (best practices, SOPs) for annotating, collecting, transporting, processing, storing, and sharing biospecimens to ensure optimal reproducibility of outcomes and the privacy of the patients (donors) through adherence to the ethical and legal requirements associated with the use of biospecimens.

6.To provide the connectivity to various biorepositories and biospecimens around the world, especially those containing rare and difficult to get biospecimens.

Small clinical trials may be appropriate and even a necessity in various contexts that include, but are not limited, to rare diseases. Being able to conduct them with scientific rigor is of increasing importance in the current regulatory and scientific environment. FDA's Office of Orphan Products Development (OOPD), in collaboration with NIH's Office of Rare Diseases Research (ORDR), is conducting a new and improved 2-day course entitled, "The Science of Small Clinical Trials”. This course will present an overall framework and provide training in the scientific aspects of designing and analyzing clinical trials based on small study populations.

This course aims to bring together subject experts and stakeholders to discuss examples of small clinical trials and to identify strategies and trial designs that are conducive to overcoming the problem of executing clinical trials using small study populations.

Individuals with disabilities who need reasonable accommodation to participate in this presentation should contact Tracy Starr, Office of Biorepositories and Biospecimen Research, 301-496-2598 and/or the Federal Relay (1-800-877-8339).